The Trump administration has awarded $1.6 billion to Novavax, a biotechnology company based in Maryland, to develop, produce, and distribute a coronavirus vaccine. Novavax says it hopes to produce 100 million doses of the vaccine by late 2020.
“More good news about COVID-19 therapeutics is constantly emerging, and President Trump’s commitment to supporting lifesaving therapeutics will help deliver these products to American patients without a day’s delay,” said HHS Secretary Alex Azar in a statement.
“We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation’s population,” said Stanley C. Erck, President and Chief Executive Officer of Novavax.
Federal assistance will finance Phase 3 clinical trials for Novavax’s vaccine candidate and facilitate production in a newly-acquired facility in the Czech Republic. According to STAT, the company will also establish production sites in India and Asia.
“I think that takes care of a lot of the issues around potential border closings, so that vaccine will be available for the globe,” Erck told STAT.
Novavax received $388 million from the Coalition for Epidemic Preparedness Innovations for Phase 1 and 2 clinical trials, with results expected later this month. A pre-published paper demonstrated the effectiveness of the vaccine in non-human subjects. The vaccine is administered in two doses, but the possibility exists for a single-dose inoculation.
The grant functions as part of the federal government’s “Operation Warp Speed,” a collaboration between numerous federal agencies, including the CDC, NIH, and FDA, to expedite vaccine development and production. Public-private partnerships will ostensibly allow the research, development, and licensure processes to occur simultaneously rather than successively.
“Operation Warp Speed is creating a portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said Sec. Azar.
Regeneron, a NY-based therapeutics developer, also received a $450 million grant today. Seven other companies, ranging from biotechnology to medical manufacturing, have received contracts from the federal government as part of Operation Warp Speed, and more are expected to participate. Congress announced nearly $10 billion in available funds for the operation.
Francis Collins, director of the NIH, explained the rationale behind Operation Warp Speed: “To put it really simply, drug development is a series of boxes you have to check—very complicated boxes, but boxes nonetheless…OWS requires checking each and every one of those boxes just like we would for any other project, but we aren’t going one by one down the list. We’re aiming to check as many of them simultaneously as we can.”
Responding to criticism about the operation’s alleged lack of transparency, Collins testified on July 2 that “we are strictly adhering to and following all required regulatory and safety requirements required for vaccine development. We are not sacrificing the safety of the vaccine in order to expedite its development.”
He claimed the federal government would shoulder the investment risk.